A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Rosuvastatin on LDL-C in Patients With Hypercholesterolaemia

AstraZeneca

Status and phase: Begins enrollment in 2 months; Phase 3

Conditions: Hypercholesterolaemia

Treatments: Drug: Placebo to match laroprovstat/rosuvastatin 4; Drug: Rosuvastatin 3; Drug: Placebo to match laroprovstat/rosuvastatin 1,2,3; Drug: Rosuvastatin 4; Drug: Placebo to match Rosuvastatin; Combination Product: laroprovstat/rosuvastatin 4; Drug: Rosuvastatin 1; Combination Product: laroprovstat/rosuvastatin 1; Combination Product: laroprovstat/rosuvastatin 3; Combination Product: laroprovstat/rosuvastatin 2; Drug: Rosuvastatin 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT07619118

2026-526258-15-00 (EU Trial (CTIS) Number)

D7961C00001

Details and patient eligibility

About

The purpose of this study is to evaluate the effect on low-density lipoprotein-cholesterol (LDL-C) and the safety and tolerability of a fixed dose combination (FDC) of laroprovstat/rosuvastatin versus rosuvastatin alone in patients with hypercholesterolaemia with either a history of a clinical atherosclerotic cardiovascular disease (ASCVD) event or at increased risk for a first clinical ASCVD event.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant must be ≥ 18 years of age
• Participants must be on a stable dose of all background LLTs
• The stable statin dose should be judged as their maximally tolerated dose
• Participants should have either history of a clinical ASCVD event or be at increased risk for a first clinical ASCVD event

Exclusion criteria

• Asian origin
• Uncontrolled severe hypertension
• Uncontrolled T2DM
• Inadequately treated hypothyroidism

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 8 patient groups

laroprovstat/rosuvastatin dose 1

Experimental group

Description:

Patient will receive a daily dose of laroprovstat/rosuvastatin 1 and a placebo to match rosuvastatin 1

Treatment:

Combination Product: laroprovstat/rosuvastatin 1

Drug: Placebo to match Rosuvastatin

rosuvastatin dose 1

Active Comparator group

Description:

Patient will receive a daily dose of rosuvastatin 1 and placebo to match laroprovstat/rosuvastatin 1

Treatment:

Drug: Rosuvastatin 1

Drug: Placebo to match laroprovstat/rosuvastatin 1,2,3

laroprovstat/rosuvastatin dose 2

Experimental group

Description:

Patient will receive a daily dose of laroprovstat/rosuvastatin 2 and a placebo to match rosuvastatin 2

Treatment:

Combination Product: laroprovstat/rosuvastatin 2

Drug: Placebo to match Rosuvastatin

rosuvastatin dose 2

Active Comparator group

Description:

Patient will receive a daily dose of rosuvastatin 2 and placebo to match laroprovstat/rosuvastatin 2

Treatment:

Drug: Rosuvastatin 2

Drug: Placebo to match laroprovstat/rosuvastatin 1,2,3

laroprovstat/rosuvastatin dose 3

Experimental group

Description:

Patient will receive a daily dose of laroprovstat/rosuvastatin 3 and a placebo to match rosuvastatin 3

Treatment:

Combination Product: laroprovstat/rosuvastatin 3

Drug: Placebo to match Rosuvastatin

rosuvastatin dose 3

Active Comparator group

Description:

Patient will receive a daily dose of rosuvastatin 3 and placebo to match laroprovstat/rosuvastatin 3

Treatment:

Drug: Placebo to match laroprovstat/rosuvastatin 1,2,3

Drug: Rosuvastatin 3

laroprovstat/rosuvastatin dose 4

Experimental group

Description:

Patient will receive a daily dose of laroprovstat/rosuvastatin 4 and a placebo to match rosuvastatin 4

Treatment:

Combination Product: laroprovstat/rosuvastatin 4

Drug: Placebo to match Rosuvastatin

rosuvastatin dose 4

Active Comparator group

Description:

Patient will receive a daily dose of rosuvastatin 4 and placebo to match laroprovstat/rosuvastatin 4

Treatment:

Drug: Rosuvastatin 4

Drug: Placebo to match laroprovstat/rosuvastatin 4